Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Solution dependent contraindications:
Haemofiltration/- dialysis dependent contraindications:
The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.
Phoxilium should not be used in patients with hyperkalemia (see section 4.3). The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis.
Because Phoxilium is a potassium-containing solution, hyperkalaemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalaemia does not resolve, stop administration promptly.
If hyperkalaemia develops when Phoxilium is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.
Because Phoxilium is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired phosphate concentration is achieved. If hyperphosphatemia does not resolve, stop administration promptly (See Section 4.3 Contraindication).
Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance. If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped.
Because Phoxilium contains no glucose, administration may lead to hypoglycaemia. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration of patients receiving insulin or other glucose lowering medications), but also considered in non-diabetic patients, e.g. risk for silent hypoglycemia during the procedure. If hypoglycaemia develops, use of a glucose-containing solution should be considered. Other corrective measures may be necessary to maintain desired glycaemic control.
The instructions for use (see section 6.6) must be strictly followed.
The solutions in the two compartments must be mixed before use.
Use of a contaminated solution may cause sepsis and shock
Do not administer the solution unless it is clear. Aseptic technique must be used during connection/disconnection of the line sets to the Phoxilium container.
Use only with an appropriate extracorporal renal replacement equipment.
Phoxilium may be warmed to 37°C to enhance patient comfort. Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. Phoxilium should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.
Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.
In case of hypervolaemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.
In case of hypovolaemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased.
The blood concentration of filterable/dialysable drugs may be reduced during treatment due to their removal by the haemodialyser, haemofilter or haemodiafilter. Corresponding corrective therapy should be instituted if necessary to establish the correct doses for drugs removed during the treatment.
Interactions with other medications can be avoided by correct dosage of the solution for haemofiltration and haemodialysis.
The following are examples of potential drug interactions with Phoxilium:
No effects on fertility are anticipated, since calcium, sodium, potassium, magnesium, chloride, hydrogen phosphate and hydrogen carbonate are normal constituents of the body.
There are no documented clinical data on the use of Phoxilium during pregnancy and lactation. Phoxilium should only be administered to pregnant and lactating women if clearly needed.
Not relevant.
Undesirable effects can result from the solution used or the treatment.
Bicarbonate-buffered haemofiltration and haemodialysis solutions are generally well tolerated.
The following undesirable effects have been reported from post-marketing experience. The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies cannot be estimated from the available data.
| MedDra System Organ Class | Preferred Term | Frequency |
|---|---|---|
| Metabolism and nutrition disorders | Electrolyte imbalances, e.g.:, hyperphosphataemia | not known |
| Fluid imbalance, e.g.: hypervolaemia, hypovolaemia | not known | |
| Acid-base balance disorders, e.g. metabolic acidosis, metabolic alkalosis | not known | |
| Vascular disorder | Hypotension* | not known |
| Gastrointestinal disorder | Nausea* | not known |
| Vomiting* | not known | |
| Musculoskeletal and connective tissue disorders | Muscle cramps* | not known |
* undesirable effects related generally to dialysis treatments.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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